# K093916: Neobase Non-Derivatized MSMS Kit Model 3040-001U

- Pathway: 510(k) (Traditional)
- Applicant: Perkinelmer, Inc.
- Decided: Aug 23, 2010 after 244 days
- Product code: NQL (System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry)
- Device class: 2
- Regulation: 21 CFR 862.1055
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN040002 (2004). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083130: Neobase Non-Derivatized MSMS Kit, Model 3040, Perkinelmer, Inc. (2009) Summary page 1.

## Cited in the summary but kept off the family tree
- K031878: MS2 and PerkinElmer Quattro Micro platforms. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 5.

## Most influential descendants
- K173568: NeoBase 2 Non-derivatized MSMS Kit (2018), 1 descendant of its own
- K193103: NeoBase 2 Non-derivatized MSMS Kit (2020), 0 descendants of its own

## Indications for use
The Neobase Non-derivatized MSMS reagent kit (for use on the PerkinElmer TQD MSMS Screening System) is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes (Table 1) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.

Source page: https://510kreport.com/device/K093916
Methodology: https://510kreport.com/methodology